Fatty Liver Clinical Trial
Official title:
An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
The primary objectives of this study are to assess, in patients with Type 2 diabetes
mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:
- The safety and tolerability of multiple doses of INT 747;
- The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and
glucose homeostasis;
- Effects of INT-747 on hepatocellular function as measured by assessment of liver
enzymes and biochemical markers of hepatic and metabolic function and inflammation,
and;
- Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic
acid (6-EDCA) and tauro 6-ECDCA.
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose,
parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25
mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.
The primary objective of assessing changes in insulin resistance and glucose homeostasis
will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the
end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring
adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite
concentrations; and general health and well-being.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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